The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Biosonic Ultrasonic Scaler System.
| Device ID | K983727 |
| 510k Number | K983727 |
| Device Name: | BIOSONIC ULTRASONIC SCALER SYSTEM |
| Classification | Scaler, Ultrasonic |
| Applicant | COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1999-01-20 |